Y-O Management LLC, dba Natural Remedy Store product recalled over undeclared tadalafil

Recall date

March 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Y-O Management LLC, dba Natural Remedy Store recalls Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Ant…

Recall number

D-1080-2020

FDA classification

Class I

Brand / firm

Y-O Management LLC, dba Natural Remedy Store

Sold / distributed

Distributed in GA and TX

Why it was recalled

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501